Drug FDA Class II Ongoing Quality

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

Provepharm Inc. Published Dec 25, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Provepharm Inc. or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Discoloration

Affected products (1)

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

DIHYDROERGOTAMINE MESYLATE · 2160 packs/5 ampules per pack = 10,800 ampules

NDC: 81284-411, 81284-411-00, 81284-411-05, 81284-411-10

Code info: Lot #: F9026F01, F9026F02, Exp. Date 12/2025

Affected areas

Nationwide

Timeline

Initiated

Nov 22, 2024
Published

Dec 25, 2024

Recall number: D-0150-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.